Acute Spinal Cord Injury
Conditions
Keywords
Hepatocyte Growth Factor, HGF, KP-100IT, KP-100, Intrathecal injection
Brief summary
This study is non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT, code of HGF (Hepatocyte Growth Factor ) formulation for intrathecal injection, in subjects with acute spinal cord injury.
Interventions
DRUGKP-100IT
Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
Sponsors
Kringle Pharma, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* At the time of consent (whether oral or written consent), the patient's age is over 18 years old and under 89 years old * Patients who have suffered a cervical spinal cord injury within the past 78 hours whose AIS classification was A at 66 - 78 hours after injury-Written informed consent has been obtained
Exclusion criteria
* The injury site is C1-C2 or C2-C3 * The patient cannot start rehabilitation necessary for recovery of function at an early stage, for example because tracheal intubation, tracheotomy, or mechanical ventilatory support is necessary * It is predicted that it will not be possible to administer the first dose of the study drug within 78 hours after the cervical spinal cord injury * A history of SCI (Spinal cord injury), or abnormal findings in the spinal cavity or marked breakdown of the meninges other than SCI * Efficacy and safety cannot be evaluated properly due to such as concurrent multiple external trauma or concurrent organ injury * High dose steroid therapy administered for spinal cord injury * Disease such as serious liver disorder, renal disease, heart disease, blood dyscrasia, metabolic disease, or infections requiring systemic therapy * History of malignant tumor * Participation in a clinical study or research of pharmaceuticals or medical devices within 1 month before registration * Drug allergies to drugs that will be (or may be) used * Administration of the study drug to the site of spinal cord injury is inappropriate for a reason such as intrathecal infection or intrathecal mass * Problems with the subject's ability to give informed consent in person * The subject is breastfeeding or possibly pregnant * The subject cannot be expected to survive more than 180 days after the start of administration of the study drug, in the judgement of the investigator * It is inappropriate for the subject to be included in the study, in the judgement of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time course of modified Frankel classification | up to 24weeks |
| Time course of neurological level of injury | up to 24weeks |
| Percentage of subjects improving by at least 10 points on the ASIA motor score at 12 weeks and 24 weeks after administration relative to before study drug administration | 12 weeks and 24 weeks |
| Time course of AIS classification | up to 24weeks |
| Time course of ASIA motor score (total/ upper extremity / lower upper extremity) | up to 24weeks |
| Time course of ASIA sensory score | up to 24weeks |
| Evaluation of adverse events | up to 24weeks |
| Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100IT after intrathecal administration | up to 24weeks |
Countries
Japan
Contacts
Primary ContactEtsuro Hashimura
Backup ContactDaichika Hayata
Outcome results
None listed